Ranger™ H74939419501590Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729976035), received between Feb 28, 2022 and May 21, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2023 AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 200 MM WITH 100 PERCENT STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 3 MM X 120 MM COYOTE BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 150 MM RANGER DRUG COATED BALLOON, STUDY DEVICE. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 29 PERCENT. THE TARGET LESION #002 WAS IN THE LEFT DISTAL POPLITEAL ARTERY, LEFT TIBIAL PERONEAL TRUNK AND LEFT POSTERIOR TIBIAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 3 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 80 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 4 MM X 200 MM RANGER DRUG

  Patient problems: Vascular Dissection

  MAUDE report 22065323 ↗
• MalfunctionMay 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH. A 5.0 X 150MM, 90CM RANGER (DCB) DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE AND WAS REMOVED FROM THE SHEATH WITHOUT EXPANSION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005865 ↗
• MalfunctionMar 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150MM, 90CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 6 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718543 ↗
• MalfunctionFeb 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150MM, 90CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON FIRST INFLATION AT 14 ATMOSPHERES FOR A MINUTE THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18746203 ↗
• MalfunctionFeb 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PINHOLE WAS OBSERVED IN THE BALLOON. THIS RANGER GLOBAL DCB OTW 5.0 X 150MM, 90CM WAS SELECTED FOR USE IN A PERCUTANEOUS ANGIOPLASTY PROCEDURE. THE LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), WAS SEVERELY CALCIFIED, HAD MODERATE TORTUOSITY, AND WAS 90 PERCENT STENOSED. DURING THE FIRST INFLATION ATTEMPT AT 4ATM FOR 20 SECONDS, A BALLOON RUPTURE OCCURRED, AND A PINHOLE WAS NOTED NEAR THE MIDDLE OF THE BALLOON. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW RANGER BALLOON. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISCARDED AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375786 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2021, A 5.0 X 150MM, 90CM RANGER DRUG COATED BALLOON (DCB) WAS SELECTED FOR THE TREATMENT OF A CHRONIC TOTAL OCCLUSION IN THE LEFT POPLITEAL ARTERY. THE LESION WAS 99% STENOSED, MILDLY CALCIFIED AND LOCATED IN A MODERATELY TORTUOUS ANATOMY. ON (B)(6) 2021, RESTENOSIS WAS OBSERVED IN THE TREATED LESION. SECOND TREATMENT OF THE TARGET LESION WAS PERFORMED USING A NON BOSTON SCIENTIFIC DCB. ON (B)(6) 2022, THIRD TREATMENT OF THE TARGET LESION WAS PERFORMED DUE TO RESTENOSIS. THE RESTENOSIS WAS TREATED WITH A 5.0 X 200MM, 150CM RANGER DCB AND A 7 X 40, 130CM ELUVIA DRUG-ELUTING STENT. DURING A SUBSEQUENT FOLLOW-UP IN (B)(6) 2022, ECHOCARDIOGRAM AND COMPUTED TOMOGRAPHY SCANS REVEALED AN ANEURYSM IN THE TREATED SITE. ON (B)(6) 2022 TREATMENT OF THE ANEURYSM WAS PERFORMED BY IMPLANTING A VIABAHN STENT GRAFT AND AN EPIC STENT OVER THE ANEURYSM. THE ANEURYSM WAS RESOLVED AND THE PATIENT WAS PLACED UNDER OBSERVATION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED. ACCORDING TO THE PHYSICIAN, IT IS BELIEVED THAT THERE MIGHT BE A CAUSAL RELATIONSHIP BETWEEN THE REPEATED TREATMENTS OF THE LESION IN A SHORT PERIOD OF TIME AND THE USE OF T

  Patient problems: Restenosis

  MAUDE report 14250882 ↗
• MalfunctionApr 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PINHOLE BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150MM, 90CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR THE ENDOVASCULAR THERAPY PROCEDURE. DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. AFTER DECOMPRESSION, THE BALLOON WAS ABLE TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048308 ↗
• MalfunctionFeb 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 5.0 X 150MM, 90CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE. THE 90% STENOSED TARGET LESION WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS AND LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE FIRST INFLATION, THE BALLOON WAS INFLATED FOR 30 SECONDS AT 6ATM. HOWEVER, THE BALLOON RUPTURED. A NEW RANGER BALLOON WAS SELECTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13618048 ↗